NIRT: Evaluating Oversight Models for
Active Nanostructures and Nanosystems:
Learning from Past Technologies in a
Societal Context
SES-0608791
March 15-16, 2007
Susan M. Wolf, J.D. (PI)
Efrosini Kokkoli, Ph.D. (Co-PI)
Jennifer Kuzma, Ph.D. (Co-PI)
Jordan Paradise, J.D. (Co-PI)
Gurumurthy Ramachandran, Ph.D. (Co-PI)
Research Goals
• Assessment of 6 oversight models utilizing criteria
schooled by consensus:
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drugs
medical devices
chemicals in the environment
chemicals in the workplace
gene transfer research (“gene therapy”)
genetically engineered organisms in the food supply
• Application of oversight lessons to nanobio
• Development of oversight models for nanobio
products and research
Thematic Areas
• Oversight assessment and development of
new oversight models
• Legal, policy, and ethical analysis of
oversight approaches
• Mapping technological and research areas
related to nanobio
• Development of criteria to evaluate nanobio
oversight
3 Phases
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Phase 1: Integrated Oversight Assessment of 6 Historical Models (15 mos.)
– Collect literature, develop criteria, analyze literature, draft case studies
– Draw cross-cutting conclusions across 6 oversight models and begin drafting
collaborative report and individual papers
Phase 2: Mapping the Models onto Nanobiotechnology (15 mos.)
– Develop normative recommendations for nanobio oversight using lessons
learned from Phase 1
– Refine collaborative report and individual or group-authored papers,
including comparative report and individual case studies
– Solicit feedback from stakeholders and experts
– Develop workshop series for UM students
– Plan Nov. 2009 public conference
Phase 3: Performing Scenario Analysis, Soliciting Feedback & Engaging in
Dissemination (18 mos.)
– Public conference (Nov. 2009)
– Revise consensus paper based on feedback
– Finalize consensus paper following conference
– Present at outside conferences, publish project products
Anticipated Project Products
• Publication of individual papers analyzing 6 historical
oversight models
• Publication of comparative analysis across the 6 models
• Publication of group-authored consensus paper on lessons
for nanobio oversight
• Dissemination of policy analysis and normative oversight
recommendations through hard copy, web-based resources,
and targeted efforts to reach key stakeholders
• Creation of workshop series for law & public policy students
• Public conference to present consensus report plus papers
authored by Investigators and Working Group members and
to seek public input
• Presentation of work by Investigators at outside conferences